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CTRI Number  CTRI/2025/10/095588 [Registered on: 03/10/2025] Trial Registered Prospectively
Last Modified On: 03/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Compare Hs-CRP levels in periodontitis patients with and without cardiovascular disease 
Scientific Title of Study   COMPARATIVE ANALYSIS OF HIGH-SENSITIVE C-REACTIVE PROTEIN LEVELS IN SALIVA OF PATIENTS WITH CHRONIC PERIODONTITIS WITH AND WITHOUT CARDIOVASCULAR DISEASE. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shraddha Kabra 
Designation  post graduate student 
Affiliation  AB Shetty institute of medical sciences 
Address  4th floor, department of periodontology, AB Shetty institute of medical sciences ,Mangalore ,Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  08329104470  
Fax    
Email  shraddhakabra144@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR.AMITHA RAMESH 
Designation  head of department 
Affiliation   
Address  4th floor, department of periodontology, AB Shetty institute of medical sciences ,Mangalore ,Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845407984  
Fax    
Email  dramitharamesh@nitte.edu.in  
 
Details of Contact Person
Public Query
 
Name  Shraddha Kabra 
Designation  post graduate student 
Affiliation  AB Shetty institute of medical sciences 
Address  4th floor, department of periodontology, AB Shetty institute of medical sciences ,Mangalore ,Karnataka

Dakshina Kannada
KARNATAKA
575018
India 
Phone  08329104470  
Fax    
Email  shraddhakabra144@gmail.com  
 
Source of Monetary or Material Support  
ELISA Kit from Krishgen biosystems private limited, Mumbai,Maharashtra,India 400018. phone no: 9967876632 
 
Primary Sponsor  
Name  Shraddha kabra 
Address  4th floor, department of periodontology ,AB Shetty memorial institute of medical sciences, Deralakatte , Mangalore, Karnataka,India, 575018 
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shraddha Kabra  ABSMIDS,NITTE University, Mangalore, Karnataka  4th floor, department of periodontology, AB Shetty institute of medical sciences ,Mangalore ,Karnataka
Dakshina Kannada
KARNATAKA 
08329104470

shraddhakabra144@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  for Group 1, Subjects included in the study will be patients with chronic periodontitis without cardiovascular disease having normal triglycerides and cholesterol levels
for Group 2, Subjects included in the study will be chronic periodontitis patients with coronary artery disease who are certified by the cardiology department of nearby hospitals
All patients having at least 10 natural teeth without any type of restoration except third molars
Subjects with Gingival Index according to Loe and Silness of moderate gingivitis will be considered for both groups
Subjects with clinical attachment loss greater 3mm will be considered in both the groups that is according to CDC Classification
 
 
ExclusionCriteria 
Details  For group 1, subjects with any systemic diseases and on medications.
For group 2, subjects with any systemic diseases other than coronary artery disease.
Subjects on any anti–anxiety drugs in the last 6 months.
Subjects having habits detrimental to oral health, for example smoking, consuming alcohol, betel nut chewing or using any other form of tobacco.
Patients who had undergone any periodontal treatment in the previous six months, using any orthodontic appliances or dental prosthesis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
salivary Hs-CRP levels  baseline only 
 
Secondary Outcome  
Outcome  TimePoints 
relation with periodontitis and cardiovascular disease  baseline 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Chronic periodontitis is a progressive inflammatory disease that damages the supporting structures of teeth and, if untreated, can lead to tooth mobility and loss. Beyond its oral effects, it has systemic implications, particularly in cardiovascular health. Coronary artery disease, an inflammatory atherosclerotic condition, may be influenced by the systemic inflammation associated with periodontitis.

Saliva has gained attention as a diagnostic fluid due to its easy and non-invasive collection. It has been explored for detecting biomarkers of systemic conditions like cardiovascular disease, diabetes, and rheumatoid arthritis, as well as for monitoring oral diseases such as periodontal disease and oral cancer. However, salivary content can vary depending on factors like age, smoking, and systemic health.

High-sensitivity C-reactive protein (hs-CRP) is a widely recognized marker of systemic inflammation and cardiovascular risk. Elevated hs-CRP levels have been observed in both cardiovascular disease and periodontitis, suggesting a link between these two conditions. While traditionally measured in serum, salivary hs-CRP has emerged as a convenient, cost-effective, and non-invasive alternative.

There is limited research comparing salivary hs-CRP levels in patients with chronic periodontitis with and without cardiovascular disease. This study aims to evaluate whether salivary hs-CRP can serve as a biomarker for identifying individuals at higher cardiovascular risk, explore the correlation between periodontitis severity and hs-CRP levels, and investigate the shared inflammatory pathways. Ultimately, this research seeks to establish salivary hs-CRP as a useful tool for early detection and integrated management of systemic risks in patients with chronic periodontitis.

 
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